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H.R. 1029 — what changed

An Act to amend the Federal Insecticide, Fungicide, and Rodenticide Act to improve pesticide registration and other activities under the Act, to extend and modify fee authorities, and for other purposes.

From Referred in Senate to Reported in Senate. 5 sections amended and 1 added between Referred in Senate and Reported in Senate.

Section 1 Short title; table of contents

(a)
changed Short title— This Act may be cited as the “Pesticide Registration Enhancement Act of 2017”. “Pesticide Registration Improvement Extension Act of 2017”.
(b)
Table of contents— The table of contents for this Act is as follows:

Sec. 2 Extension and modification of maintenance fee authority

(a)
Maintenance fee— Section 4(i)(1) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a–1(i)(1)) is amended—
(1)
changed in subparagraph (C), by striking “an aggregate amount of $27,800,000 for each of fiscal years 2013 through 2017” and inserting “an average amount of $31,000,000 for each of fiscal years 2017 through 2023”;2023 2018 through 2020”;
(2)
in subparagraph (D)—
(A)
changed in clause (i), by striking “$115,500 for each of fiscal years 2013 through 2017” and inserting “$129,400 for each of fiscal years 2017 through 2023”; 2023 2018 through 2020”; and
(B)
changed in clause (ii), by striking “$184,800 for each of fiscal years 2013 through 2017” and inserting “$207,000 for each of fiscal years 2017 through 2023”;2023 2018 through 2020”;
(3)
in subparagraph (E)(i)—
(A)
changed in subclause (I), by striking “$70,600 for each of fiscal years 2013 through 2017” and inserting “$79,100 for each of fiscal years 2017 through 2023”; 2023 2018 through 2020”; and
(B)
changed in subclause (II), by striking “$122,100 for each of fiscal years 2013 through 2017” and inserting “$136,800 for each of fiscal years 2017 through 2023”; 2023 2018 through 2020”; and
(4)
changed in subparagraph (I), by striking “2017” and inserting “2023”.“2023 2020”.
(b)
Prohibition on other fees— Section 4(i)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a–1(i)(2)) is amended—
(1)
by striking “during the period beginning on the date of enactment of this section and ending on September 30, 2019” and inserting “until September 30, 2025”; and
(1)
added by striking “the date of enactment of this section and ending on September 30, 2019” and inserting “the effective date of the Pesticide Registration Improvement Extension Act of 2017 and ending on September 30, 2022”; and
(2)
renumbered was (3)(4) by inserting after “registration of a pesticide under this Act” the following: “or any other action covered under a table specified in section 33(b)(3),”.
(c)
changed Extension of prohibition on tolerance fees— Section 408(m)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a(m)(3)) is amended by striking “2017” and inserting “2023”.“2023 2020”.

Sec. 3 Reregistration and Expedited Processing Fund

(a)
Authorized use of fund— Section 4(k)(2)(A) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a–1(k)(2)(A)) is amended—
(1)
in the first sentence, by striking “the fund” and inserting “the Reregistration and Expedited Processing Fund”;
(2)
changed by striking “paragraph (3),” in the first sentence and all that follows through the period at the end of the second sentence and inserting the following: “paragraph (3), to offset the costs of registration review under section 3(g), including the costs associated with any review under the Endangered Species Act of 1973 (16 U.S.C. 1531 et. seq.) required as part of the registration review, to offset the costs associated with tracking and implementing registration review decisions, including registration review decisions designed to reduce risk, for the purposes specified in paragraphs (4) and (5), and to enhance the information systems capabilities to improve the tracking of pesticide registration decisions.”;
(3)
in clause (i), by striking “are allocated solely” and all that follows through “3(g);” and inserting the following: “are allocated solely for the purposes specified in the first sentence of this subparagraph;”; and
(4)
in clause (ii), by striking “necessary to achieve” and all that follows through “3(g);” and inserting the following: “necessary to achieve the purposes specified in the first sentence of this subparagraph;”.
(b)
changed Set-Aside for review of inert ingredients and expedited processing of similar applications— Section 4(k)(3)(A) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a–1(k)(3)(A)) is amended, in the matter preceding clause (i), by striking “The Administrator shall use” and all that follows through “personnel and resources—” and inserting the following: “For each of fiscal years 2017 through 2023, 2023 2018 through 2020, the Administrator shall use between 1/9 and 1/8 of the maintenance fees collected in such fiscal year to obtain sufficient personnel and resources—”.
(c)
Set-Aside for Expedited Rulemaking and Guidance Development for certain purposes— Paragraph (4) of section 4(k) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a–1(k)) is amended to read as follows:

“(4) Expedited rulemaking and guidance development for certain product performance data requirements

changed “(A) Set-aside—For each of fiscal years 2017 through 2021, 2021 2018 through 2020, the Administrator shall use not more than $500,000 of the amounts made available to the Administrator in the Reregistration and Expedited Processing Fund for the activities described in subparagraph (B).

“(B) Products claiming efficacy against invertebrate pests of significant public health or economic importance—The Administrator shall use amounts made available under subparagraph (A) to develop, receive comments with respect to, finalize, and implement the necessary rulemaking and guidance for product performance data requirements to evaluate products claiming efficacy against the following invertebrate pests of significant public health or economic importance (in order of importance):

“(i) Bed bugs.

“(ii) Premise (including crawling insects, flying insects, and baits).

changed “(iii) Pests of pets (including pet pests controlled by spot-ons, collars, shampoos, powders, or dips).

“(iv) Fire ants.

“(C) Deadlines for guidance—The Administrator shall develop, and publish guidance required by subparagraph (B) with respect to claims of efficacy against pests described in such subparagraph as follows:

changed “(i) With respect to bed bugs, issue final guidance not later than June 30, 2017. 30 days after the effective date of the Pesticide Registration Improvement Extension Act of 2017.

“(ii) With respect to pests specified in clause (ii) of such subparagraph—

“(I) submit draft guidance to the Scientific Advisory Panel and for public comment not later than June 30, 2018; and

changed “(II) complete any response to comments received with respect to such draft guidance and finalize the guidance not later than September 30, 2020.2020 2019.

“(iii) With respect to pests specified in clauses (iii) and (iv) of such subparagraph—

“(I) submit to the Scientific Advisory Panel and for public comment draft guidance not later than June 30, 2019; and

“(II) complete any response to comments received with respect to such draft guidance and finalize the guidance not later than March 31, 2021.

changed “(D) Revision—The Administrator shall revise the guidance required by subparagraph (B) from time-to-time, time-to-time time to time, but shall permit applicants and registrants sufficient time to obtain data that meet the requirements specified in such revised guidance.

“(E) Deadline for product performance data requirements—The Administrator shall, not later than September 30, 2021, issue regulations prescribing product performance data requirements for any pesticide intended for preventing, destroying, repelling, or mitigating any invertebrate pest of significant public health or economic importance specified in clauses (i) through (iv) of subparagraph (B).”

(d)
Set-Aside for Good laboratory practices inspections— Section 4(k) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136a–1(k)) is amended—
(1)
by redesignating paragraphs (5) and (6) as paragraphs (6) and (7), respectively;
(2)
by inserting after paragraph (4) the following new paragraph:

“(5) Good laboratory practices inspections

changed “(A) Set-aside—For each of fiscal years 2017 through 2023, 2023 2018 through 2020, the Administrator shall use not more than $500,000 of the amounts made available to the Administrator in the Reregistration and Expedited Processing Fund for the activities described in subparagraph (B).

“(B) Activities—The Administrator shall use amounts made available under subparagraph (A) for enhancements to the good laboratory practices standards compliance monitoring program established under part 160 of title 40 of the Code of Federal Regulations (or successor regulations), with respect to laboratory inspections and data audits conducted in support of pesticide product registrations under this Act. As part of such monitoring program, the Administrator shall make available to each laboratory inspected under such program in support of such registrations a preliminary summary of inspection observations not later than 60 days after the date on which such an inspection is completed.”

(3)
in paragraph (7), as so redesignated, by striking “ paragraphs (2), (3), and (4)” and inserting “ paragraphs (2), (3), (4), and (5)”.

Sec. 5 Pesticide registration service fees

(a)
Extension and modification of fee authority— Section 33(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(b)) is amended—
(1)
in paragraph (2)—
(A)
in the heading, by striking “pesticide registration”; and
(B)
in subparagraph (A), by inserting “or for any other action covered by a table specified in paragraph (3)” after “covered by this Act that is received by the Administrator on or after the effective date of the Pesticide Registration Improvement Act of 2003”;
(2)
in paragraph (5)—
(A)
changed in the heading, by striking “pesticide registration applications” and inserting “covered application”; and “covered applications”; and
(B)
by striking “pesticide registration application” both places it appears and inserting “covered application”;
(3)
in paragraph (6)—
(A)
in subparagraph (A)—
(i)
by striking “pesticide registration”; and
(ii)
by striking “October 1, 2013, and ending on September 30, 2015” and inserting “October 1, 2019, and ending on September 30, 2021”;
(B)
in subparagraph (B)—
(i)
by striking “pesticide registration”; and
(ii)
by striking “2015” both places in appears, and inserting “2021”; and
(C)
added in
(A)
added in subparagraph (A), by striking “pesticide registration”; and
(B)
renumbered was (2)(5)(4) in subparagraph (C), by striking “revised registration service fee schedules” and inserting “service fee schedules revised pursuant to this paragraph”;
(4)
in paragraph (7)—
(A)
in subparagraph (A)—
(i)
by striking “covered pesticide registration” and inserting “covered application”; and
(ii)
by inserting before the period at the end the following: “, except that no waiver or fee reduction shall be provided in connection with a request for a letter of certification (commonly referred to as a Gold Seal letter)”; and
(B)
in subparagraph (F)(i), by striking “pesticide registration”; and
(5)
in paragraph (8)—
(A)
in subparagraph (A), by striking “pesticide registration”;
(B)
in subparagraph (B)(i), by striking “pesticide registration”; and
(C)
in subparagraph (C)—
(i)
in clause (i), by striking “pesticide registration” and inserting “covered”; and
(ii)
in clause (ii)(I), by striking “pesticide registration” and inserting “covered”.
(b)
Pesticide registration fund set-Asides for worker protection, partnership grants, and pesticide safety education— Section 33(c)(3)(B) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(c)(3)(B)) is amended—
(1)
in the heading, by inserting “, partnership grants, and pesticide safety education” after “Worker protection”;
(2)
in clause (i)—
(A)
changed by striking “2017” and inserting “2023”; “2023 2020”; and
(B)
by inserting before the period at the end the following:“, with an emphasis on field-worker populations in the United States”;
(3)
changed in clause (ii), by striking “2017” and inserting “2023”; “2023 2020”; and
(4)
changed in clause (iii), by striking “2017” and inserting “2023”.“2023 2020”.
(c)
Reforms To reduce decision time review periods— Section 33(e) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(e)) is amended—
(1)
changed by striking “Pesticide Registration Improvement Extension Act of 2012” and inserting “Pesticide Registration Enhancement Improvement Extension Act of 2017”; and
(2)
by inserting at the end the following new sentence: “Such reforms shall include identifying opportunities for streamlining review processes for applications for a new active ingredient or a new use and providing prompt feedback to applicants during such review process.”.
(d)
changed Decision time review periods— Section 33(f) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(f)(1)) (7 U.S.C. 136w–8(f)) is amended—
(1)
in paragraph (1)—
(A)
changed by striking “Pesticide Registration Improvement Extension Act of 2012” and inserting “Pesticide Registration Enhancement Improvement Extension Act of 2017”; and
(B)
by inserting after “covered pesticide registration actions” the following: “or for any other action covered by a table specified in subsection (b)(3)”;
(2)
in paragraph (3), by striking subparagraph (C) and inserting the following new subparagraph:

“(C) applications for any other action covered by a table specified in subsection (b)(3).”

(3)
in paragraph (4)(A)—
(A)
by striking “a pesticide registration application” and inserting “a covered application”; and
(B)
by striking “covered pesticide registration application” and inserting “covered application”.
(e)
Reporting requirements— Section 33(k) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(k)) is amended—
(1)
changed in paragraph (1) by striking “2017” and inserting “2023”; “2023 2020”; and
(2)
in paragraph (2)—
(A)
in subparagraph (D), by striking clause (i) and inserting the following new clause:

“(i) the number of pesticides or pesticide cases reviewed and the number of registration review decisions completed, including—

“(I) the number of cases cancelled;

“(II) the number of cases requiring risk mitigation measures;

“(III) the number of cases removing risk mitigation measures;

“(IV) the number of cases with no risk mitigation needed; and

“(V) the number of cases in which risk mitigation has been fully implemented;”

(B)
in subparagraph (G)—
(i)
in clause (i)—
(I)
by striking “section 4(k)(4)” and inserting “paragraphs (4) and (5) of section 4(k)”; and
(II)
by striking “that section” and inserting “such paragraphs”;
(ii)
by striking clauses (ii), (iii), (iv), (v), and (vi);
(iii)
by inserting after clause (i) the following new clause:

“(ii) implementing enhancements to—

“(I) the electronic tracking of covered applications;

“(II) the electronic tracking of conditional registrations;

“(III) the endangered species database;

“(IV) the electronic review of labels submitted with covered applications; and

“(V) the electronic review and assessment of confidential statements of formula submitted with covered applications; and”

(iv)
by redesignating clause (vii) as clause (iii);
(C)
in subparagraph (I), by striking “and” at the end;
(D)
in subparagraph (J), by striking the period at the end and inserting a semicolon; and
(E)
by adding at the end the following new subparagraphs:

“(K) a review of the progress made in developing, updating, and implementing product performance test guidelines for pesticide products that are intended to control invertebrate pests of significant public health importance and, by regulation, prescribing product performance data requirements for such pesticide products registered under section 3;

changed “(L) a review of the progress made in the priority review and approval of new pesticides to control vector-born public health pests invertebrate public health pests that may transmit vector-borne disease for use in the United States, including each territory or possession of the United States, and United States military installations globally;

“(M) a review of the progress made in implementing enhancements to the good laboratory practices standards compliance monitoring program established under part 160 of title 40 of the Code of Federal Regulations (or successor regulations);

“(N) the number of approvals for active ingredients, new uses, and pesticide end use products granted in connection with the Design for the Environment program (or any successor program) of the Environmental Protection Agency; and

“(O) with respect to funds in the Pesticide Registration Fund reserved under subsection (c)(3), a review that includes—

“(i) a description of the amount and use of such funds—

“(I) to carry out activities relating to worker protection under clause (i) of subsection (c)(3)(B);

“(II) to award partnership grants under clause (ii) of such subsection; and

“(III) to carry out the pesticide safety education program under clause (iii) of such subsection;

“(ii) an evaluation of the appropriateness and effectiveness of the activities, grants, and program described in clause (i);

“(iii) a description of how stakeholders are engaged in the decision to fund such activities, grants, and program; and

“(iv) with respect to activities relating to worker protection carried out under subparagraph (B)(i) of such subsection, a summary of the analyses from stakeholders, including from worker community-based organizations, on the appropriateness and effectiveness of such activities.”

(f)
Termination of effectiveness— Section 33(m) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(m)) is amended—
(1)
changed in paragraph (1), by striking “2017” and inserting “2023”; “2023 2020”; and
(2)
in paragraph (2)—
(A)
in subparagraph (A)—
(i)
changed by striking “Fiscal year 2018.—During fiscal year 2018” and inserting “Fiscal year 2024.—During fiscal year 2024”; and “Fiscal year 2021.—During fiscal year 2021”; and
(ii)
changed by striking “2017” and inserting “2023”;“2023 2020”;
(B)
in subparagraph (B)—
(i)
changed by striking “Fiscal year 2019.—During fiscal year 2019” and inserting “Fiscal year 2025.—During fiscal year 2025”; and “Fiscal year 2022.—During fiscal year 2022”; and
(ii)
changed by striking “2017” and inserting “2023”;“2023 2020”;
(C)
changed in subparagraph (C), by striking “September 30, 2019.—Effective September 30, 2019” and 2019”and inserting “September 30, 2025.—Effective September 30, 2025”; and 2019” and inserting “September 30, 2022.—Effective September 30, 2022”; and
(D)
changed in subparagraph (D), by striking “2017” both places it appears and inserting “2023”.“2023 2020”.

Sec. 6 Revision of tables regarding covered pesticide registration applications and other covered actions and their corresponding registration service fees

Paragraph (3) of section 33(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136w–8(b)) is amended to read as follows:

“(3) Schedule of covered applications and other actions and their registration service fees—Subject to paragraph (6), the schedule of registration applications and other covered actions and their corresponding registration service fees shall be as follows:”

added “(3) Schedule of covered applications and other actions and their registration service fees—Subject to paragraph (6), the schedule of registration applications and other covered actions and their corresponding registration service fees shall be as follows:”

Sec. 7 Effective date

added

added The amendments made by this Act take effect on October 1, 2017.